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Detection of Plasmatic Cell-free BRAF and NRAS Mutations : a New Tool for Monitoring Patients With Metastatic Malignant Melanoma Treated With Targeted Therapies or Immunotherapy ( MALT ) (MALT)

Primary Purpose

Malignant Melanoma Stage IV, Malignant Melanoma Stage III

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
quantification of BRAF and NRAS mutation
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malignant Melanoma Stage IV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients in metastatic situation for a malignant melanoma inoperable stage IIIB or IIIC or stage IV
  • In first line of treatment by a targeted therapy (only or in association) or immunotherapy
  • Every histological types of cutaneous or mucous malignant melanoma (excepted choroid melanomas)
  • The tumor must be mutates for BRAF or NRAS
  • The mutation status must have been realized in the Laboratory Pathology Clinical and Experimental (LPCE) of the CHU de Nice analysis of the status on-site metastatic mutational and/or primitive tumor must
  • Membership or beneficiary of the national insurance scheme

Exclusion Criteria:

  • Histories of cancer or other synchronous cancer
  • Pregnant, breast-feeding Women. A pregnancy test will be practiced to the women old enough to procreate.
  • Vulnerable People: adults under guardianship, patients deprived of freedom, minor

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patient with malignant melanoma

    Arm Description

    Patient with advanced or metastatic malignant melanoma (stage IIIB inoperable or IIIC or stage IV) will have a first blood test before any treatment, then at day 15 or 30 after initiation of therapy, and every two months until recurrence or progression for a maximum of 22 months.

    Outcomes

    Primary Outcome Measures

    Quantify plasmatic BRAF and NRAS mutation determine by PCR digitale in µg/ml before treatment
    Study the longitudinal monitoring of cell-free the kinetics of the plasma mutation of BRAF and NRAS mutation in µg/ml and comparing them with imaging (based on RECIST criteria) and with the activity of the lactate dehydrogenase in serum ( LDH) in U/l .

    Secondary Outcome Measures

    Compare the results obtained by PCR digitale from the cell-free with the results on FFPE tissue samples
    Identify genomic alterations and mutations of resistances in a restricted subgroup of patient by New Generation Sequencing analysis

    Full Information

    First Posted
    March 26, 2018
    Last Updated
    April 11, 2018
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03493230
    Brief Title
    Detection of Plasmatic Cell-free BRAF and NRAS Mutations : a New Tool for Monitoring Patients With Metastatic Malignant Melanoma Treated With Targeted Therapies or Immunotherapy ( MALT )
    Acronym
    MALT
    Official Title
    Detection of Plasmatic Cell-free BRAF and NRAS Mutations: a New Tool for Monitoring Patients With Metastatic Malignant Melanoma Treated With Targeted Therapies or Immunotherapy ( MALT )
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2018 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Nice

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main objective of this project is to perform a longitudinal monitoring of BRAF and NRAS cell-free DNA in a large cohort of metastatic melanomas patients before treatment and during the follow-up. Results will be compared with clinical data as imaging (based on RECIST criteria) and the activity of lactate dehydrogenase in serum (LDH).
    Detailed Description
    During a consultation of follow-up for an advanced malignant melanoma (stage IIIb or IIIC or IV), an investigator presents the study to the patient and give him the note of information and the informed consent. The patient can benefit from a reflexion period of of 7 days. In case of agreement, a first blood draw will take place before initiation of any treatment. Between D15 and D30 a second blood draw will be taken. Then a blood draw will be necessary every two months until recurrence or progression of the disease for a maximum of 22 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malignant Melanoma Stage IV, Malignant Melanoma Stage III

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patient with malignant melanoma
    Arm Type
    Experimental
    Arm Description
    Patient with advanced or metastatic malignant melanoma (stage IIIB inoperable or IIIC or stage IV) will have a first blood test before any treatment, then at day 15 or 30 after initiation of therapy, and every two months until recurrence or progression for a maximum of 22 months.
    Intervention Type
    Biological
    Intervention Name(s)
    quantification of BRAF and NRAS mutation
    Intervention Description
    Quantification of cell-free BRAF and NRAS mutations with digital PCR
    Primary Outcome Measure Information:
    Title
    Quantify plasmatic BRAF and NRAS mutation determine by PCR digitale in µg/ml before treatment
    Time Frame
    Day 0
    Title
    Study the longitudinal monitoring of cell-free the kinetics of the plasma mutation of BRAF and NRAS mutation in µg/ml and comparing them with imaging (based on RECIST criteria) and with the activity of the lactate dehydrogenase in serum ( LDH) in U/l .
    Time Frame
    Month 24
    Secondary Outcome Measure Information:
    Title
    Compare the results obtained by PCR digitale from the cell-free with the results on FFPE tissue samples
    Time Frame
    Month 24
    Title
    Identify genomic alterations and mutations of resistances in a restricted subgroup of patient by New Generation Sequencing analysis
    Time Frame
    Month 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients in metastatic situation for a malignant melanoma inoperable stage IIIB or IIIC or stage IV In first line of treatment by a targeted therapy (only or in association) or immunotherapy Every histological types of cutaneous or mucous malignant melanoma (excepted choroid melanomas) The tumor must be mutates for BRAF or NRAS The mutation status must have been realized in the Laboratory Pathology Clinical and Experimental (LPCE) of the CHU de Nice analysis of the status on-site metastatic mutational and/or primitive tumor must Membership or beneficiary of the national insurance scheme Exclusion Criteria: Histories of cancer or other synchronous cancer Pregnant, breast-feeding Women. A pregnancy test will be practiced to the women old enough to procreate. Vulnerable People: adults under guardianship, patients deprived of freedom, minor
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elodie LONG-MIRA, MD
    Phone
    04 92 03 88 55
    Email
    long-mira.e@chu-nice.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elodie LONG-MIRA, MD
    Organizational Affiliation
    Centre Hospitalier Universitaire de Nice
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12925966
    Citation
    de Vries E, Bray FI, Coebergh JW, Parkin DM. Changing epidemiology of malignant cutaneous melanoma in Europe 1953-1997: rising trends in incidence and mortality but recent stabilizations in western Europe and decreases in Scandinavia. Int J Cancer. 2003 Oct 20;107(1):119-26. doi: 10.1002/ijc.11360.
    Results Reference
    background
    PubMed Identifier
    17496922
    Citation
    Dhillon AS, Hagan S, Rath O, Kolch W. MAP kinase signalling pathways in cancer. Oncogene. 2007 May 14;26(22):3279-90. doi: 10.1038/sj.onc.1210421.
    Results Reference
    background
    PubMed Identifier
    23715574
    Citation
    Bahadoran P, Allegra M, Le Duff F, Long-Mira E, Hofman P, Giacchero D, Passeron T, Lacour JP, Ballotti R. Major clinical response to a BRAF inhibitor in a patient with a BRAF L597R-mutated melanoma. J Clin Oncol. 2013 Jul 1;31(19):e324-6. doi: 10.1200/JCO.2012.46.1061. Epub 2013 May 28. No abstract available.
    Results Reference
    result

    Learn more about this trial

    Detection of Plasmatic Cell-free BRAF and NRAS Mutations : a New Tool for Monitoring Patients With Metastatic Malignant Melanoma Treated With Targeted Therapies or Immunotherapy ( MALT )

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